SYNTHES 3.5MM SPRING PLATE by SYNTHES (USA)

The Synthes 3.5mm Spring Plate is a variation of the Synthes one-third tubular plate with collar which utilizes two sharp spikes at the bottom surface and a pre-bent convex shape to aid in the reduction of small bone fragments while conforming to bony uneven surfaces. The plate incorporates a 1 - 10 hole design in lengths ranging from 19.5mm - 132mm and accepts either 3.5mm cortex or pelvic screws. In addition the plates are manufactured from Stainless Steel and Commercially Pure Titanium and provided STERILE and NON STERILE.

AI/ML Overview

The provided text does not contain information about acceptance criteria and a study proving the device meets those criteria. The document is a 510(k) summary for the Synthes 3.5mm Spring Plate, outlining its device name, classification, predicate device, description, intended use, and a claim of substantial equivalence to the predicate device. It also includes the FDA's clearance letter.

Therefore, I cannot provide the requested information, as there is no mention of:

Acceptance criteria table or reported device performance against such criteria.
Details about a study, including sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth type, or training set information.

Summary

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SEP 1 2006

3.0 510(k) Summary

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Sponsor:	Synthes (USA)1301 Goshen ParkwayWest Chester, PA 19380(610) 719-6500
Device Name:	Synthes 3.5mm Spring Plate
Classification:	Class II, §888.3030 - Plate, Fixation, Bone (HRS)
Predicate Device:	Synthes One-Third Tubular LCP Plates, with collar
Device Description:	The Synthes 3.5mm Spring Plate is a variation of the Synthesone-third tubular plate with collar which utilizes two sharp spikesat the bottom surface and a pre-bent convex shape to aid in thereduction of small bone fragments while conforming to bonyuneven surfaces. The plate incorporates a 1 - 10 hole design inlengths ranging from 19.5mm - 132mm and accepts either 3.5mmcortex or pelvic screws. In addition the plates are manufacturedfrom Stainless Steel and Commercially Pure Titanium andprovided STERILE and NON STERILE.
Intended Use:	The Synthes 3.5mm Spring Plate is intended for pelvic andacetabular reconstructive surgery and fracture fixation of the distalfibula.
SubstantialEquivalence:	Comparative information presented supports substantialequivalence.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 1 2006

Synthes (USA) % Ms. Deborah Jackson Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380

Re: K061973 Trade/Device Name: Synthes (USA) 3.5mm Spring Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: July 7, 2006 Received: July 12, 2006

Dear Ms. Jackson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Ms. Deborah Jackson

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Adubare Buelum

Mark N. Melkerson Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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2.0	Indications for Use
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510(k) Number (if known):	K061973
Device Name:	Synthes (USA) 3.5mm Spring Plate
Indications for Use:	The Synthes 3.5mm Spring Plate is intended for pelvic and acetabular reconstructive surgery and fracture fixation of the distal fibula.

Prescription Use	X
(Per 21 CFR 801.109)

AND/OR

Over-The-Counter Use
(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Inelus

Division Sign-Off Division of General, Restorative and Neurological Devices

510(k) Number 406/973

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.